FDA UDI
In Commercial Distribution
🇺🇸 United States
AdDent
DI: D86911008001
·
Model: Microlux 2
·
ADDENT, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AdDent
- Primary DI
- D86911008001
- Version / Model
- Microlux 2
- Catalog Number
- 110080
- Company Name
- ADDENT, INC.
- Labeler DUNS
- 099490679
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-06-01
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- a8c63657-6967-426a-b282-d483375ad7d0
Device Description
The Microlux 2 Transilluminator is used for detecting Anterior and Posterior Caries. It also helps to visualize crown fractures, root canal orifice, and root fractures. Microlux 2 applications include an accessory for Proximal Caries detection, and Oral Cancer Screening.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NTK | Caries Detector, Laser Light, Transmission | Dental | 872.1745 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12352 | Fibreoptic dental light | A mains electricity (AC-powered) device designed for use in dentistry to project an intense and focused beam of light directly into or around the oral cavity of a patient via a fibreoptic cable to illuminate the site of a dental examination or procedure. The illumination is produced by the light source of the device, a dedicated light bulb, and is transmitted via the fibreoptic cable which is attached to a dental handpiece held, or a headband worn, by dental staff. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D86911008001 | HIBCC |
Customer Contacts
- Phone
- 2037780200
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K062961 | 000 |